CSA vs CSV: Modernizing Software Validation in Regulated Industries

This article explores the key differences between CSV and the new CSA, the FDA’s guidance, and how organizations can adopt modern techniques to optimize their validation efforts. 

Understanding CSA and its Importance 

What is CSA? 

Computer Software Assurance (CSA) is a risk-based approach to software validation introduced by the FDA as a modern evolution to traditional Computer System Validation (CSV). CSA emphasizes critical thinking and focuses validation activities on areas that pose the highest risk to patient safety and product quality. This builds upon the CSV approach, which often involved extensive documentation and validation effort regardless of risk. CSA encourages validation teams to prioritize activities based on the potential impact of software failures, ensuring that software meets its intended use and performs reliably. CSA allows for a more streamlined and efficient validation process, optimizing resources while maintaining regulatory compliance. The FDA’s guidance on Computer Software Assurance, recently released in September 2025, clarifies expectations and promotes a more flexible and adaptable approach to software validation. 

Importance of Software Validation 

Software validation is paramount in industries like life science, where computerized systems directly impact patient safety and product quality. FDA 21 CFR Part 11 mandates rigorous validation of software systems to ensure data integrity, accuracy, and reliability. Effective software validation, whether through a classic CSV approach or the updated CSA guidance, ensures that software functions as intended and mitigates potential risks associated with software failures. A robust validation plan, incorporating a risk-based approach, is essential for demonstrating that the software meets pre-defined specifications and is fit for its intended purpose. Software validation is a critical component of maintaining product quality and protecting patient well-being while remaining compliant to regulatory demands.  

CSA vs CSV: Key Differences 

Traditional CSV often involves a validation process requiring extensive testing and documentation for all computer systems, regardless of their potential impact on patient safety and product quality. In contrast, CSA as introduced by the FDA encourages validation teams to prioritize assurance activities, leading to a more efficient and targeted validation effort. This update is crucial for the consideration of risk levels associated with the computerized system; high-risk systems warrant more rigorous testing and documentation per CSA. 

FDA Guidelines for CSA 

The FDA’s guidance specifically outlines how to apply critical thinking and leverage vendor testing to reduce the overall validation effort. By aligning validation plans with the actual risk posed by specific computer systems, organizations can optimize their resources and improve the efficiency of their software assurance for production processes.  

The FDA’s CSA guidance encourages manufacturers to: 

• Apply critical thinking to validation planning 

• Use unscripted testing for low-risk functions 

• Accept vendor documentation and digital evidence 

• Align validation with actual risk and intended use 

Modern Validation Techniques 

The adoption of CSA necessitates the use of modern validation techniques that align with its risk-based approach. Instead of relying solely on extensive documentation and testing, validation teams are now employing techniques like automated and exploratory testing, continuous integration, digital evidence and agile development methodologies. These modern techniques facilitate a more iterative and adaptive validation process, allowing for faster feedback loops and quicker identification of potential issues within computer systems. A key aspect of modern validation is the utilization of vendor testing and documentation, reducing the need for redundant testing.  

Risk-Based Validation in Practice 

The essence of a risk-based approach within CSA lies in the strategic allocation of validation effort. By understanding the potential impact of computer systems on product quality and patient safety, validation teams can prioritize assurance activities effectively. This means focusing on the software used in critical processes while streamlining the validation process for low-risk applications. A well-defined validation plan, guided by a thorough risk assessment, is essential for successfully transitioning from the rigid approach of traditional CSV to the more adaptable CSA.  

Application in Production and Quality Systems 

When applying a risk-based approach to CSA in production and quality system software, it is vital to meticulously assess the potential risks associated with each software component. By aligning validation plans with the actual risk profile of the software systems, organizations can optimize their validation effort. This strategy is in line with FDA 21 CFR Part 11, ensuring software assurance for production and compliance, while making the transition from CSV to CSA. 

When applying CSA to production and quality system software, these are some of the things to take into consideration: 

1. Assess Intended Use: Identify how each system supports regulated processes. 

1. Evaluate Risk: Determine potential impact on product quality and patient safety. 

1. Tailor Validation Activities: Use appropriate testing and documentation based on risk. 

1. Leverage Vendor Assurance: Accept and use supplier testing records and certifications. 

1. Update SOPs and Training: Align internal procedures with CSA principles. 

This approach supports compliance with FDA 21 CFR Part 11, Part 820, and upcoming FDA Quality Management System Regulation (QMSR) harmonization with ISO 13485 in 2026. 

Conclusion: Final Thoughts 

The transition from a CSV approach to a CSA approach marks a pivotal evolution toward smarter, risk-based validation practices. By focusing on critical thinking, intended use, and process risk, CSA enables organizations to streamline validation efforts, reduce unnecessary documentation, and align with modern development methodologies.  

Read more about how ACE eQMS can help your company adapt to this guidance from the FDA.